Health
FDA clears C2N Diagnostics' blood test to aid in Alzheimer's disease evaluation
The PrecivityAD2 test uses mass spectrometry to measure biomarkers and offers a less invasive alternative to spinal taps and brain scans.
The short version
- The U.S. Food and Drug Administration has cleared the PrecivityAD2 blood test to help identify amyloid plaques associated with Alzheimer's disease.
- Developed by Washington University startup C2N Diagnostics, the test measures ratios of specific amyloid and tau proteins using high-resolution mass spectrometry.
- FDA clearance is expected to expand marketing to health systems and could facilitate insurance coverage, making the test more accessible to patients.
Key facts
- The FDA cleared the PrecivityAD2 blood test for marketing to assist clinicians in evaluating patients for Alzheimer's disease pathology.[Hacker News]
- The test measures ratios of amyloid (Aβ42 and 40) and tau proteins (p-tau217 and total tau217) in blood samples using high-resolution mass spectrometry.[Hacker News]
- The underlying technology for the test was originally developed at the Washington University School of Medicine in St. Louis by researchers Randall J. Bateman and David M. Holtzman.[Hacker News]
- The test was commercialized and validated by C2N Diagnostics, a Washington University startup co-founded by Bateman and Holtzman in 2007.[Hacker News]
- Prior research indicated that the PrecivityAD2 test can diagnose Alzheimer's amyloid pathology with more than 90% accuracy, performing similarly to spinal taps and brain scans.[Hacker News]